Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OCU410 · 2 trials · 2 indications
Rate of change (slope) of square root-transformed GA lesion area (√mm²/year) from baseline to Month 12 in treated eyes compared to control eyes as assessed by fundus autofluorescence (FAF) measurements
The primary endpoint is safety, determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
We will use Slit-lamp Biomicroscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits.
We will use Indirect ophthalmoscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits.
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.
Measured by letter score. A higher score represents better vision
Measured by applanation or rebound tonometry with confirmation with Goldmann tonometer if IOP is outside normal range (8-21mmHg).
| Arm | Type | Description |
|---|---|---|
| OCU410 | EXPERIMENTAL | OCU410 Single Sub Retinal Injection, 200 µL, 1×10\^10 vg/eye |
| Untreated Control Arm | NO_INTERVENTION | Control Arm (Untreated) |
| Phase1 Dose Escalation- Low Dose (2.5×10E10 vg/mL): | EXPERIMENTAL | Low Dose (2.5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the low dose concentration. |
| Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL): | EXPERIMENTAL | Medium Dose (5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the medium dose concentration. |
| Phase1 Dose Escalation- High Dose (1.5×10E11 vg/mL): | EXPERIMENTAL | High Dose (1.5×10E11 vg/mL): Subjects will receive a subretinal injection in the high dose concentration. |
| Phase 2 Dose Expansion: Maximum tolerated dose (MTD) from Phase 1-Randomized Arm | EXPERIMENTAL | Maximum tolerated dose (MTD) from Phase 1: Subjects will receive a subretinal injection in the MTD concentration. |
| Phase 2 Dose Expansion: Lower Dose from Phase 1-Randomized Arm | EXPERIMENTAL | Subjects will receive a subretinal injection of OCU410 in a Lower Dose concentration. |
| Control Arm | NO_INTERVENTION | No Intervention Control Arm: Subject will not receive any active study intervention |
| Name | Type | Description |
|---|---|---|
| OCU410 | BIOLOGICAL | Subretinal Injection |
Inclusion Criteria: 1. Subjects 55 years of age or older at consent. 2. BCVA of ≥25 ETDRS letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen Equivalent) and ≤80 ETDRS Letters (20/25 Snellen Equivalent) in the study eye. 3. Fundus autofluorescence (FAF) im...
OCU410 is an investigational therapy being developed for geographic atrophy and dry age-related macular degeneration. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied in patients with these retinal conditions.
OCU410 is a monoclonal antibody being developed by Ocugen, Inc. for geographic atrophy and dry age-related macular degeneration. As a monoclonal antibody, it is designed to bind to a specific target involved in the disease process, though the exact molecular target has not been disclosed.
OCU410 is being developed by Ocugen, Inc., a biopharmaceutical company. Ocugen is conducting clinical trials to evaluate the safety and efficacy of OCU410 for geographic atrophy and dry age-related macular degeneration.
OCU410 is currently in Phase 3 clinical development. It is being studied in a Phase 3 trial for dry age-related macular degeneration, and it has also completed a Phase 1 trial for geographic atrophy. OCU410 is investigational and not yet approved by the FDA.
OCU410 is being evaluated in two clinical trials. NCT06018558 is a Phase 1 study in geographic atrophy with 60 participants, which is active but not recruiting. NCT07770828 is a Phase 3 study in dry age-related macular degeneration with 237 participants, which is currently recruiting.
OCU410 is a distinct investigational drug developed by Ocugen, Inc. It is not known to be the same as any other approved or marketed medication. It is being studied specifically for geographic atrophy and dry age-related macular degeneration.